SEDAL3X- acetaminophen, aspirin, caffeine tablet 
OPMX LLC

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Sedal 3X

Drug facts

Active ingredients
(in each caplets)

Acetaminophen 250 mg
Aspirin 250 mg (NSAID)*
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug

Uses

Uses
temporarily relieves minor aches and pains due to:
headache
a cold
arthritis
muscular aches
sinusitis
toothache
premenstrual and menstrual cramps

Warnings

Allergy alert

Aspirin may cause a severe allergic reaction, which may include:
hives
shock
facial swelling
asthma (wheezing)

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take:
more than 8 tablets in 24 hours, wich is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Stomach bleeding warning

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
are age 60 or older
have had stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
have 3 or more alcoholic drinks every day while using this product
take more or for a longer time than directed

Caffeine warning

The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness and, occasionally, rapid heartbeat.

Do not use

if you ever had an allergic reaction to acetaminophen, aspirin, or any other pain reliever/fever reducer
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if you have

liver disease
stomach bleeding warning applies to you
you have a history of stomach problems, such as heartburn
you have high blood pressure, heart disease, liver cirrhosis or kidney disease
you have asthma
you are taking a diuretic

Ask a doctor or pharmacist before use if you are taking

a prescription drug for diabetes, gout, or arthritis

taking any other drug or are under a doctor's care for any serious condition

Stop use and ask a doctor if

you experience any of the following signs of stomach bleeding:
feel faint
have bloody or black stools
vomit blood
have stomach pain that does not get better
an allergic reaction occurs. Seek medical help right away if:
any new symptoms appear
ringing in the ears or loss of hearing occurs
pain gets worse or lasts for more than 10 days
fever gets worse or lasts for more than 3 days
painful area is red or swollen

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery

Keep out of reach of children.

Overdose warning

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

do not use more than directed
drink a full glass of water with each dose
adults and children 12 years and over:
take 2 tablets every 6 hours
do not take more than 8 tablets in 24 hours
children under 12 years: ask a doctor

Other information

store at 25°C (77°F) excursions permitted between 15-30°C (59-86°F)
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAPS IS BROKEN OR MISSING

Inactive ingredients

corn starch, crospovidone, hypromellose, microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide

Manufactured in:
GMP Registered Facility in the USA


Made for:

inov FARMACEUTIQUE

Exclusively distributed by:
OPMX
Chula Vista, CA 91910
PHONE: 619-600-5632

Sedal3x

Acetaminophen 250 mg

Aspirin 250 mg
Caffeine 65 mg

Pain Reliever

40 Caplets

PRINCIPAL DISPLAY PANEL - 40 CAPLETS

NDC 69729-055-40

Sedal3x

Acetaminophen 250 mg Pain reliever

Aspirin 250 mg Pain reliever
Caffeine 65 mg Pain reliever

40 Caplets

Sedal3X 40_caps

SEDAL3X 
acetaminophen, aspirin, caffeine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69729-055
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
CROSPOVIDONE (UNII: 2S7830E561)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize17mm
FlavorImprint Code S53
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69729-055-401 in 1 CARTON09/07/2022
140 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01309/07/2022
Labeler - OPMX LLC (029918743)
Establishment
NameAddressID/FEIBusiness Operations
ELYSIUM PHARMACEUTICALS LIMITED915664486analysis(69729-055) , label(69729-055) , manufacture(69729-055) , pack(69729-055)

Revised: 6/2024
Document Id: 1a161b94-99d7-840a-e063-6394a90acc00
Set id: e9089f8b-3d23-5c81-e053-2995a90a4202
Version: 3
Effective Time: 20240604
 
OPMX LLC